FDA Inspection
Bioindustria Laboratorio Italiano Medicinali S.p.ABioindustria Laboratorio Italiano Medicinali S.p.A – FDA Inspection, Oct 18, 2016
Record Details
This FDA Inspection record concerns Bioindustria Laboratorio Italiano Medicinali S.p.A, with an inspection on October 18, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- October 18, 2016
- Product Type
- Human Drugs
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ID · e30e0010-80a1-43a8-8bcf-09a2a20f5728
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996822
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Bioindustria Laboratorio Italiano Medicinali S.p.A
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bioindustria Laboratorio Italiano Medicinali S.p.A
- FDA Inspection 1217681 - 2023-02-24
- FDA Inspection 1059528 - 2018-06-15
- FDA Inspection 924406 - 2015-03-10
- FDA Inspection 840406 - 2013-06-25
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